Trial reportCephalalgia : an international journal of headache2018
Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study.
Trial report in Cephalalgia : an international journal of headache, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
77 citing papers in PubMed, 6 syntheses or guidelines pooled it, 191 citations in OpenAlex.
- Efficacy, IHS Guideline Adherence, and Methodological Quality of Noninvasive Neuromodulation Clinical Trials in Migraine and Cluster Headache: A Systematic Review.European journal of neurology · 2026Pooled it
- Noninvasive Vagus Nerve Stimulation for Cluster Headache and Migraine: A Health Technology Assessment.Ontario health technology assessment series · 2025Pooled it
- Research hotspots and frontiers of cluster headaches: a bibliometric analysis.Frontiers in neurology · 2024Pooled it
- Vagus nerve stimulation for primary headache disorders: An anatomical review to explain a clinical phenomenon.Cephalalgia : an international journal of headache · 2019Pooled it
- Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis.Cephalalgia : an international journal of headache · 2019Pooled it
- Non-invasive neuromodulation for migraine and cluster headache: a systematic review of clinical trials.Journal of neurology, neurosurgery, and psychiatry · 2019Pooled it
- Safety and efficacy of occipital nerve stimulation as treatment of chronic cluster headache: an investigator-initiated, double-blind, randomized, placebo-controlled study.The journal of headache and pain · 2026Trial
- Efficacy of transauricular vagus nerve stimulation for the treatment of chemotherapy-induced painful peripheral neuropathy: a randomized controlled exploratory study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Trial
- A Prospective, Multicenter Study to Assess the Safety and Efficacy of Translingual Neurostimulation Plus Physical Therapy for the Treatment of a Chronic Balance Deficit Due to Mild-to-Moderate Traumatic Brain Injury.Neuromodulation : journal of the International Neuromodulation Society · 2021Trial
- Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment.Cephalalgia : an international journal of headache · 2020Trial
- Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial.Cephalalgia : an international journal of headache · 2019Trial
- Consistent effects of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: additional findings from the randomized, sham-controlled, double-blind PRESTO trial.The journal of headache and pain · 2018Trial
- Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study.Neurology · 2018Trial
- Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study.Cephalalgia : an international journal of headache · 2018Trial
- Vagus nerve stimulation modulates LPS-induced epileptogenicity: the role of inflammation suppression.Research square · 2026Article
- Article
- Without getting under your skin: non-invasive stimulation activates the vagus nerve.Frontiers in neuroscience · 2026Review
- Non-Invasive Neuromodulation in the Treatment of Headache.Current neurology and neuroscience reports · 2025Review
- Non-Invasive Vagus Nerve Stimulation in Cluster Headache: A Clinical Practice Guideline.Pain practice : the official journal of World Institute of Pain · 2025Review
- Hallmarks of primary headache: part 3 - cluster headache.The journal of headache and pain · 2025Review
17 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 9 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background Clinical observations and results from recent studies support the use of non-invasive vagus nerve stimulation (nVNS) for treating cluster headache (CH) attacks. This study compared nVNS with a sham device for acute treatment in patients with episodic or chronic CH (eCH, cCH). Methods After completing a 1-week run-in period, subjects were randomly assigned (1:1) to receive nVNS or sham therapy during a 2-week double-blind period. The primary efficacy endpoint was the proportion of all treated attacks that achieved pain-free status within 15 minutes after treatment initiation, without rescue treatment. Results The Full Analysis Set comprised 48 nVNS-treated (14 eCH, 34 cCH) and 44 sham-treated (13 eCH, 31 cCH) subjects. For the primary endpoint, nVNS (14%) and sham (12%) treatments were not significantly different for the total cohort. In the eCH subgroup, nVNS (48%) was superior to sham (6%; p < 0.01). No significant differences between nVNS (5%) and sham (13%) were seen in the cCH subgroup. Conclusions Combing both eCH and cCH patients, nVNS was no different to sham. For the treatment of CH attacks, nVNS was superior to sham therapy in eCH but not in cCH. These results confirm and extend previous findings regarding the efficacy, safety, and tolerability of nVNS for the acute treatment of eCH.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.